ACES Diagnostics Research Demonstrates Potential of LymeSeek™ to Improve Detection of Early Lyme Disease

PHOENIX, Ariz. (Oct. 5, 2026) — A new peer-reviewed study published in the Journal of Clinical Microbiology finds that LymeSeek™, a single-tier Lyme disease diagnostic test developed by ACES Diagnostics and its research collaborators, accurately detected clinically diagnosed early Lyme disease cases that tested negative using current standard-of-care two-tier serology tests. The findings address one of the most challenging periods in Lyme disease diagnosis: the first weeks of infection, when conventional serologic testing can have limited sensitivity and patients may face diagnostic uncertainty. 

The study, “Multiplex single-tier LymeSeek™ test improves sensitivity during the diagnostic gray zone of early Lyme disease,” evaluates LymeSeek™, a multiplex bead-based flow immunoassay designed to detect IgM and IgG antibody responses to a novel combination of eight Borrelia burgdorferi antigens. The test uses a proprietary machine learning-developed algorithm to analyze patterns of antibody binding and provide a single “detected” or “not detected” result. 

The research found that LymeSeek™ achieved 90% sensitivity and 93% specificity across the initial 467-sample training and validation cohort. In a separate evaluation of samples from 50 patients with early Lyme disease, LymeSeek™ identified 100% of cases within 15–30 days of illness onset and 90% within two weeks. 

Lyme disease is particularly difficult to confirm during the early stages of infection. Standard and modified two-tier serologic tests have recognized limitations during the first one to three weeks, and many patients may not present with a classic erythema migrans rash. This can create a diagnostic gray zone in which clinical signs and symptoms suggest Lyme disease, but laboratory testing has not yet confirmed it. The new study was specifically designed to evaluate whether LymeSeek™ could improve detection in that gray zone. 

“Early diagnosis remains one of the most important challenges in Lyme disease because the tests clinicians rely on today can have limited sensitivity during the first weeks of infection,” said Tammy Crawford, Founder & CEO, ACES Diagnostics. “These findings demonstrate the potential of LymeSeek™ to provide clinicians with meaningful diagnostic information during precisely that period of uncertainty, when timely treatment can make a critical difference for patients.” 

The study also included a preliminary assessment of reproducibility following transfer of the LymeSeek™ assay from its original academic research environment at Tulane University to the manufacturing environment at Protavio Ltd. in Greece. In this distinct cohort of more than 250 individuals, the assay achieved 90% sensitivity and 98% specificity, with performance remaining consistent following the technology transfer. 

The findings represent an important milestone in ACES Diagnostics’ efforts to advance LymeSeek™ from research toward clinical use. The company is preparing to begin clinical trials of LymeSeek™ in October 2026 at three laboratory sites, marking the next phase in the company’s efforts to advance the test toward regulatory clearance and clinical use. ACES Diagnostics’ goal is to pursue FDA clearance for LymeSeek™ and bring the diagnostic test to market by early Q2 2027. 

Additional analysis of a subset of 30 samples clinically diagnosed with Lyme disease but serologically negative by standard two-tier testing provided further insight into LymeSeek™’s potential in cases where conventional testing may not identify infection. LymeSeek™ detected 70% of cases enrolled with erythema migrans (EM) and 60% of cases enrolled with symptoms consistent with early Lyme but without EM. 

ACES Diagnostics’ development of LymeSeek™ is supported by Bay Area Lyme Ventures, the venture philanthropy initiative of Bay Area Lyme Foundation focused on accelerating promising innovations in Lyme disease diagnostics, therapeutics, and digital health technologies. Bay Area Lyme Ventures has supported ACES Diagnostics as part of its mission to advance promising innovations from research to clinical development and commercialization. 

The Lyme Disease Biobank, a program of Bay Area Lyme Foundation, has contributed to this study and the broader research ecosystem supporting advances in Lyme disease research. With specimens from more than 1,250 participants, the Biobank provides biological samples to approved researchers working to understand Lyme disease better and develop improved diagnostics and therapeutics. 

“For more than a decade, Bay Area Lyme Foundation has invested in the research and innovation needed to address significant gaps in Lyme disease diagnosis and treatment,” said study co-author Liz Horn, PhD, MBI, Principal Investigator, Lyme Disease Biobank. “These results from ACES Diagnostics and LymeSeek are encouraging and demonstrate the potential for innovative diagnostic approaches to help address the challenges of detecting Lyme disease early. We are proud to support ACES Diagnostics as the company advances this work toward clinical use.”

The researchers note that additional studies are planned, including further reproducibility studies and evaluation of LymeSeek™’s ability to distinguish antibody responses associated with early infection from antibodies that may persist after infection resolves. FDA clearance of LymeSeek™ as an in vitro diagnostic test through the 510(k) pathway has been initiated. 

“These results reinforce the scientific foundation behind our approach to Lyme disease diagnostics,” said study co-author Holly Ahern, Chief Scientific Officer, ACES Diagnostics. “Our goal is to help close the diagnostic gap that exists during early infection and ultimately give healthcare providers a more sensitive tool to support clinical decision-making.” 

The publication and upcoming clinical trials represent important milestones for ACES Diagnostics as the company works to advance LymeSeek™ toward FDA clearance and expand access to more accurate Lyme disease diagnostics. 

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To find out more about how ACES Diagnostics is revolutionizing testing for Lyme disease, visit ACESDiagnostics.com. 

About ACES Diagnostics Inc. 

ACES Diagnostics Inc. is a biotechnology company that develops cutting-edge diagnostic tools for Lyme disease. With a team of experienced researchers and a commitment to improving patient outcomes, ACES Diagnostics is poised to revolutionize the early detection and treatment of Lyme disease. Investors interested in helping bring an accurate diagnostic test to market can learn more at ACES Diagnostics. 

About Lyme Disease Biobank 

Lyme Disease Biobank (LDB), a program of Bay Area Lyme Foundation, is a nonprofit organization working to accelerate research on Lyme disease and other tick-borne infections. With a collection of biological specimens from more than 1,250 participants, including blood, serum, plasma, urine, and tissue, LDB provides much-needed samples to approved researchers working to understand tick-borne diseases better and to develop improved diagnostic tests and therapeutics. Blood and urine samples are collected from the Northeast, Upper Midwest, and West Coast areas of the U.S., and tissue samples are collected throughout the country. Researchers interested in obtaining samples should visit www.lymebiobank.org or contact info@lymebiobank.org. 

About Bay Area Lyme Ventures 

Bay Area Lyme Ventures, Bay Area Lyme Foundation’s venture philanthropy initiative, is focused on accelerating promising innovations in Lyme disease diagnostics, therapeutics, and digital health technologies. As the only venture philanthropy fund devoted to advancing solutions for Lyme disease, Bay Area Lyme Ventures is designed to help fast-track promising technologies from research toward clinical development and commercialization, ensuring that vital solutions can reach patients who need them most. Bay Area Lyme Ventures has supported ACES Diagnostics as part of its mission to accelerate promising innovations that could improve outcomes for patients with Lyme disease and other tick-borne illnesses. 

About Bay Area Lyme Foundation 

Bay Area Lyme Foundation, a national organization committed to making Lyme disease easy to diagnose and simple to cure, is the leading public charity sponsor of innovative Lyme disease research in the US. A 501 (c) (3) organization based in Silicon Valley, Bay Area Lyme Foundation collaborates with world-class scientists and institutions to accelerate medical breakthroughs for Lyme disease. It is also dedicated to providing reliable, fact-based information so that prevention and the importance of early treatment are common knowledge. Historically, a pivotal donation from the LaureL STEM fund covered all overhead costs through 2024. In 2023, a Bay Area Lyme Endowment was formed, allowing 100% of all donor contributions to the Bay Area Lyme Foundation to go directly to research and prevention programs in perpetuity. For more information about Lyme disease or to get involved, visit www.bayarealyme.org or call us at 650-530-2439.